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Pfizer asks FDA to approve booster dose of COVID vaccine …

(Adds details from interviews, quotes from doctors)

By Michael Erman and Julie Steenhuysen

NEW YORK, July 8 (Reuters) – Pfizer Inc plans to ask U.S. regulators to approve a booster dose of its COVID-19 vaccine within the next month, the drugmaker’s top researcher said Thursday based on evidence of greater risk of re-infection six months after inoculation and spread of the highly contagious Delta variant.

Pfizer Chief Scientific Officer Mikael Dolsten said the recently reported decline in vaccine efficacy in Israel was mainly due to infections in people who had been vaccinated in January or February. The country̵

7;s health ministry said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64% in June.

“The Pfizer vaccine is very active against the Delta variant,” Dolsten said in an interview. But after six months, he said, “there is likely to be a risk of reinfection as antibodies, as predicted, decrease.”

Pfizer did not release the full set of Israeli data on Thursday, but said it would be released soon.

“It’s a small dataset, but I think the trend is accurate: six months out, since Delta is the most contagious variant we’ve seen, it can cause infections and mild illness,” Dolsten said.

Pfizer’s own data from the US showed an erosion of vaccine effectiveness to the mid-80s after six months, Dolsten said, against the variants circulating there in the spring.

He stressed that data from Israel and the United Kingdom suggest that the vaccine, even with declining antibody levels, remains around 95% effective against severe disease.

The vaccine, developed with German partner BioNTech SE, showed 95% efficacy in the prevention of symptomatic COVID-19 in a clinical trial conducted by the companies last year.

Dolsten said early data from the company’s own studies show that a third booster dose generates antibody levels five to ten times higher than after the second dose, suggesting that a third dose will offer promising protection.

He said several countries in Europe and elsewhere have already approached Pfizer to discuss booster doses, and that some may begin administering them before a possible U.S. permit.

Dolsten said he believes booster footage is particularly important in older age groups.

Pfizer expects the COVID-19 vaccine to be a significant revenue contributor for years and has expected sales of $ 26 billion. Dollars from the shot in 2021. Global spending on COVID-19 vaccines and booster shots could, according to US health, amount to 157 billion. data firm IQVIA Holdings.

Dr. Eric Topol, professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, said basing the decision on declining antibody protection ignores the role of important other parts of the immune response, including memory B cells, which can produce antibodies as needed. they are challenged by the virus.

“You need better studies to be able to claim that. It’s not just neutralizing antibodies,” Topol said.

Pfizer plans to launch a placebo-controlled power trial with the 10,000-participant booster soon. This investigation will run during the fall, Dolsten said, meaning it will not be completed before the company submits to the Food and Drug Administration.

Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center, said that although Pfizer manages to get its booster approved for use by the FDA, it is only the first step. The booster is still to be reviewed and recommended by advisers to the U.S. Centers for Disease Control and Prevention.

“It’s by no means automatic,” he said. Schaffner said realistically that most of the public health bandwidth in the United States is still focused on encouraging Americans to get their first and second doses of the vaccine.

The FDA declined to comment on Pfizer’s plans.

Because boosters will drive increased demand for vaccines, as much of the world is still unvaccinated, Dolsten said, Pfizer is looking at ways to increase production.

It is already targeting the production of 3 billion doses this year and 4 billion doses next year. Dolsten declined to give a forecast for exactly how many more doses the company could add, but said “we can intensify billion after billion in ’22.”

Pfizer has previously said that people probably need a booster dose. But some researchers have questioned when or if it is necessary.

Dolsten also said that Pfizer and BioNTech are designing a new version of the vaccine targeted at the Delta variant, but said the companies do not believe the current version needs to be replaced to combat the variant. (Reporting by Michael Erman; Additional Reporting by Julie Steenhuysen in Chicago; Editing by Dan Grebler)

Our Standards: Thomson Reuters Trust Principles.

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